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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S (2BO)TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ESR8182400
Device Problems Break (1069); Positioning Problem (3009)
Patient Problem No Information (3190)
Event Date 04/19/2019
Event Type  Injury  
Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
 
Event Description
According to the available information,tubing breakage near pump.
 
Event Description
Additional information received stated tubing breakdown at pump; right cylinder malposition.
 
Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the evaluation, additional event information and updated codes.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
 
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Brand Name
(2BO)TITAN OTR INFRA ZERO ANG
Type of Device
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
3050
DA  3050
MDR Report Key8641925
MDR Text Key146112672
Report Number2125050-2019-00405
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932487542
UDI-Public05708932487542
Combination Product (y/n)N
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberESR8182400
Device Catalogue NumberESR818
Device Lot Number3714825
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/19/2019
Initial Date FDA Received05/24/2019
Supplement Dates Manufacturer Received04/19/2019
Supplement Dates FDA Received08/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
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